ACHIEVES EXPLORATORY ENDPOINT OF EFFICACY FOR ANTI-CANCER TECHNOLOGY
At the maximum recommended starting dose (MRSD) (0.35 milligram per square centimetre) of its lead compound, TLD-1433, at the 90-day cystoscopy analysis, Theralase Technologies Inc. (TLT.V) has achieved the exploratory end point of efficacy in patients inflicted with non-muscle invasive bladder cancer (NMIBC).
These three patients come from a population that has failed standard of care and have remained drug resistant after the standard first line bacillus calmette guerin (BCG) course of treatments.
The exploratory efficacy end point is being reported at 90 days, in the first three patients treated, in the first part of a phase Ib clinical study.
The study is entitled "A Phase Ib Trial of Intravesical Photodynamic Therapy in Patients with Non-Muscle Invasive Bladder Cancer at High Risk of Progression Who are Refractory to Therapy with Bacillus Calmette-Guerin ('BCG') and Who are Medically Unfit for or Refuse a Cystectomy."
The study is being used to evaluate TLD-1433 for the primary end point of safety and tolerability, secondary end point of pharmacokinetics (movement and exit of drug within tissue), and exploratory end point of efficacy.
The company previously announced on May 26, 2017, that the primary and secondary objectives for the first three patients treated in the study had successfully been achieved.
The exploratory outcome end point in the study is recurrence-free survival (RFS). RFS is defined as the interval from day zero (day of treatment with TLD-1433 photodynamic therapy (PDT)) to documented recurrence or death from any cause, whichever occurs first. Recurrence is defined as any new tumour growth (for example any biopsy-confirmed new or recurrent tumour), evaluated at 90 days for the first three patients treated at the MRSD (0.35 milligram per cubic centimetre) and primarily at 90 days for the next six patients treated at the therapeutic dose (0.70 milligram per cubic centimetre) and secondarily at 180 days posttreatment.
The first three patients have demonstrated no recurrence of NMIBC lesions at the 90-day cystoscopy analysis. One patient has presented with some reddened areas of the bladder wall, which will be biopsied at a future surgical date. Further clinical analysis will be conducted on the patients according to the approved clinical protocol.
An additional six patients for the second part of the study are currently being enrolled, to be treated at a therapeutic dose of the PDC (0.70 milligram per cubic centimetres) for NMIBC, using its novel PDT technology.
Dr. Arkady Mandel, chief scientific officer of the company, stated, "The achievement of the exploratory outcome measure of efficacy for the treatment of NMIBC at 90 days, in the first three patients treated, for the first part of the study, by the company is extremely encouraging. I look forward to following the clinical reports and complete patient data to further validate these results at the scheduled clinical analyses defined by the approved clinical protocol."
Dr. Mandel continued: "Theralase's PDT approach is demonstrating remarkable safety, tolerability and efficacy for the Bacillus Calmette-Guerin (BCG) refractory and highly recurrent papillary (Ta) transitional cell carcinoma NMIBC population. Since the PDT procedure has been well tolerated and patients are able to undergo a repeat of the procedure, if required, this PDT treatment offers considerable therapeutic advantages."
Roger Dumoulin-White, president and chief executive officer of Theralase, stated: "The company is ecstatic that after decades of hard work the company, in the first three patients treated, at the 90-day cystoscopy follow-up, at a MRSD (0.35 mg/cubic cm) of TLD-1433, that the primary end point of safety and tolerability, secondary end point of pharmacokinetics (movement and exit of drug within tissue) and now exploratory end point of efficacy have been achieved. I wish to thank the entire Theralase board and employees, the clinical and scientific team, and the medical and scientific advisory board, who have provided their knowledge, experience and worked tirelessly to make this day a reality."
About Theralase Technologies Inc.
Theralase Technologies in its therapeutic laser technology (TLT) division designs, manufactures, markets and distributes patented superpulsed laser technology indicated for the treatment of chronic knee pain, and in off-label use, the elimination of pain, reduction of inflammation and dramatic acceleration of tissue healing for numerous nerve, muscle and joint conditions. Theralase's photodynamic therapy (PDT) division researches and develops specially designed molecules called photodynamic compounds (PDCs), which localize to cancer cells and then when laser light activated, effectively destroy them.